MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN® SAFETY; I.V. SAFETY CATHETER

Model Number	4251601-020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in china: "blood leakage." according to the customer: "the nurse had not yet extracted the needle core during the puncture.The back of the needle holder keeps emitting blood.The nurse denied repeated punctures and denied loosening the needle core to puncture the catheter.The video shows that there is a leakage at the end of the catheter and the needle seat.Causes a large amount of blood to overflow.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Evidence at disposal: no sample received but a video clip was provided.From the clip, observed an introcan safety g20 wing connected to extension set and leaking at attachment between the capillary and hub housing.The actual condition of the complaint sample (damage on capillary surface, capillary condition near horn area and metal bush area) cannot be identified based on customer video.Device history record (dhr): reviewed the device history record for batch number 22f01g8922 and there were no defect encountered during in process and final control inspection.Reviewed assembly process: this product is assembled on automated assembly machines equipped with vision system and test stations.Along the machines, there is catheter leakage test station.Parts found leak is out of the inspection criteria will be detected and rejected by machines automatically.The in-line test equipment is subject of a frequent calibration and a regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in-time and would be mitigated.The process cards of the complaint batch show no abnormalities.Manufacturing control: besides the in-line test stations, in-process quality control (ipqc) will conduct leakage test using air tightness at 300 kpa/30 seconds (3 bar/30 seconds) and high-pressure test 300 psi (20.7 bar) for 10 seconds.The results for the complaint batch were reported as passed.Instruction for use (ifu) review: according to ifu, never reinsert the needle inside the catheter once the needle has been partially or completely withdrawn as it may pierce and/or severe the catheter.Do not bend the catheter and/or needle during insertion, advancement, or removal of the needle.Conclusion: as no sample was received, further evaluation was not possible.The batch records show no abnormality during the manufacturing process.Complaint is not confirmed.This report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: INTROCAN® SAFETY
• Common Device Name: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17260999
• Report Number: 9610825-2023-00300
• Device Sequence Number: 20304663
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K982805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4251601-020
• Device Catalogue Number: 4253566-03
• Device Lot Number: 22F01G8922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown